Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Phase 1

Terminated

• Conditions: Solid Tumor
• Interventions: Drug: ADG116

• Registration Number: NCT04111445
• Lead Sponsor: Adagene Inc

Brief Summary

This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-29
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

• Pregnant or nursing females.
• Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
• Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
• Any active autoimmune disease or documented history of autoimmune disease.
• Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
• Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade 2.
• History of clinically significant cardiac disease.
• Uncontrolled current illness.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADG116	ADG116	-

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing dose-limiting toxicities	From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Number of participants experiencing clinical and laboratory adverse events (AEs)	From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)

Trial Locations

Locations (1)

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States